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Documents recently released as part of the on-going Pradaxa lawsuits suggest that the manufacturers of the controversial anticoagulant knew that some patients may need medical monitoring for potential bleeding events, but attempted to coverup the clinical data.
The internal emails, documents and memos from the drug maker Boehringer Ingelheim were obtained as part of the discovery process in the federal Pradaxa litigation, and were unsealed last week by U.S. District Judge David R. Herndon.
According to a report by the New York Times, the documents suggest that the drug maker had clinical data showing that some patients metabolize Pradaxa differently than others and might need medical monitoring. However, the lack of a need for medical monitoring was one of the main selling points of the anticopagulant, which was marketed as superior to the decades-old blood thinner warfarin because it is easier to use.
The documents suggest that Boehringer Ingelheim employees were so concerned about the findings of a research paper written by a company clinical program director, Paul. A. Reilly, that some suggested that the public should never hear of such conclusions. That paper was ultimately published last week in the Journal of the American College of Cardiology.
The exchanges show executives and other researchers warning that the paper would undermine much of the Pradaxa marketing campaign. However, others within the company acknowledged that the data was something the public needed to know, but suggested that it had to be released in a “smart” way that did not threaten Pradaxa’s potential sales.
While Reilly’s paper concludes that patients may see better outcomes if doctors tailor Pradaxa doses for specific patient characteristics, the documents reveal that it once said more. The company or researchers appear to have removed references to a patient’s optimal blood-level range, according to the New York Times review.
Boehringer Ingelheim has indicated that the changes were a normal part of the discussion and decisions made about such a paper and that the blood level portions were removed because they concluded that there was not a single blood-level range that applied to all patients.
There are currently about 2,000 product liability lawsuits pending in the federal court system against Boehringer Ingelheim, which all involve similar allegations that side effects of Pradaxa caused users of the anticoagulant to suffer severe and sometimes fatal bleeding problems.
Since August 2012, the federal Pradaxa litigation has been consolidated as part of an MDL, which is centralized before Judge Herndon in the Southern District of Illinois to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
As part of the coordinated management of the cases, Judge Herndon has scheduled a series of early trial dates in the Pradaxa MDL, known as bellwether cases. These trials are set to begin between August 2014 and February 2015, with the outcomes designed to help the parties gauge how juries are likely respond to certain evidence and testimony that may be repeated throughout a large number of cases.
The new documents were revealed after Boehringer Ingelheim was sanctioned for about $900,000 for acting in bad faith and hiding or destroying documents that may have been damaging to its case in Pradaxa litigation. Juries will be told about the company’s transgressions when the cases go to trial, Judge Herndon has declared.
Pradaxa Bleeding Concerns
Pradadxa (dabigatran) is a relatively new anticoagulant therapy that was approved by the FDA in October 2010. It was the first member of a new class of medications that are promoted as superior alternatives to warfarin, also known by the brand name Coumadin, for stroke prevention. However, shortly after its introduction, Pradaxa began to rack up a record number of adverse event reports after patients experienced uncontrolled bleeding events.
Warfarin, sold under the brand name Coumadin, has been the go-to anticoagulant for decades. While Pradaxa was promoted as easier to use, because it requires less monitoring by the doctor during treatment, concerns have emerged about the lack of an effective reversal agent to stop the blood thinning effects of the medication.
Unlike warfarin, which can be quickly reversed with a dose of vitamin K and plasma, there is no available reversal agent for Pradaxa. While some studies have shown that the chances of bleeding may be about the same with the two drugs, evidence continues to emerge highlighting how Pradaxa bleeding problems may pose a more serious risk, since hemorrhages are typically harder to stop.
During the first full year the drug was on the market in the United States, the Institute for Safe Medication Practices (ISMP) found that adverse event reports involving Pradaxa problems surpassed all other medications regularly monitored by the group. FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 patient deaths.
All of the claims pending throughout the federal court system involve similar allegations and the outcomes of the early bellwether trials may influence Pradaxa settlement negotiations in a number of other cases.